Events

Rappel de INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par EDWARDS LIFESCIENCES (CANADA) INC..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    149686
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2015-05-08
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notes supplémentaires dans les données
  • Cause
    Edwards lifesciences has identified a potential safety risk which may occur during the use of the intraclude intra-aortic occlusion device (icf100) used in cardiopulmonary bypass surgery. edwards has received a limited number of reports regarding device damage on the strain relief near the hub area. some of the reports have also indicated blood leakage in this area. when damage exists blood loss can occur because blood can fill the device between the lumen shaft and the strain rerlief and leak from the area. no injuries or blood transfusions have been reported. in a worst case scenario with no mitigation blood loss can occur during use of the device.

Device

INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
  • Modèle / numéro de série
    Model Catalog: ICF100 (Lot serial: ALL)
  • Description du dispositif
    INTRACLUDE INTRA-AORTIC OCCLUSION DEVICE
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.